OstomyNCT02401412

The Advocate Study

A study testing Test Ostomy Barrier in people with Ostomy, run by Hollister Incorporated at 12 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Hollister Incorporated is studying stoma related cost of care related to a new ostomy skin barrier that is designed to maintain adhesive properties and good peristomal skin health compared to other currently marketed barriers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Ostomy
What is being tested?: Test Ostomy Barrier
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 170 participants
Where: 12 sitesin 2 countries
Study dates: 16 Mar 2015to 3 Feb 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ostomy patients who:
Have healthy peristomal skin
Are within 12 weeks post op

Who cannot join

Ostomy patients who:
Have a fistula, wound, lesion or suspected infection in the peristomal area
Are in-patient in healthcare facility

Trial locations and contacts

12 sites in 2 countries.

Country

City, postcode or hospital

12 sites in 2 countries

United States8 sites

University of Chicago Medicine
Chicago, Illinois, 60637
Klein's Orthopedic & Medical Supply
Cuyahoga Falls, Ohio, 44223
Jupiter Medical Center
Jupiter, Florida, 33458
Restored Images
Kansas City, Missouri, 64119
Indiana Health Ball Memorial University
Muncie, Indiana, 47303
Stoia Consultants
Riverside, California, 92508
Winter Haven Hospital
Winter Haven, Florida, 33881
St. Elizabeth Hospital
Youngstown, Ohio, 44504

Other trials in United States

Canada4 sites

Lakeside Medicine Center
Kelowna, British Columbia, V1M 3C2
Pharmasave
Nanaimo, British Columbia, V9S 5W4
Ostomy Care Centre
New Westminster, British Columbia, V3M 2T5
Rouge Valley Health System
Toronto, Ontario, M1E 489

Other trials in Canada

About this study

Official title: A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact.

Conditions: Ostomy
Being tested: Test Ostomy Barrier, Control Ostomy Barrier

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Test Ostomy BarrierDevice
Control Ostomy BarrierDevice

Study groups in NCT02401412
Study group	Role	What they receive
Test Ostomy Barrier	Other	The test product is a new Hollister ostomy barrier. Receives: Device: Test Ostomy Barrier
Control Ostomy Barrier	Other	The control product is a currently marketed Hollister ostomy barrier. Receives: Device: Control Ostomy Barrier

What is being measured

The primary outcome is the main question the study is designed to answer.

Stoma Related Cost of Care
12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.
Measured: 12 weeks

Secondary outcomes (1)

Peristomal Skin Complication Rate
Observed 8 week Peristomal Skin Complication (PSC) rate. The validated Ostomy Skin Tool DET score was used to describe the status of the peristomal skin. Subjects were deemed to have had a PSC if the DET score was above zero due to anything other than normal postoperative healing and/or scar tissue, or the DET score increased above the normal score obtained at a previous visit.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 20153 Feb 2017

First posted27 Mar 2015 (estimated)
Study start16 Mar 2015
Primary completion20 Jan 2017
Study completion3 Feb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OstomyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02401412
Sponsor's protocol ID: 5787-O
Status last verified: Jun 2018
First submitted: 24 Mar 2015
Last updated: 11 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Recruiting
Conducting Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up for Post-discharge Ostomy Patients to Reduce Hospital Readmission
Ostomy
Recruiting
ColoSeal™ ICD System Safety and Feasibility Studies
Colorectal Cancer
Active, not recruiting
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
Rectal Cancer Surgery

All Ostomy trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact.
ClinicalTrials.gov ID: NCT02401412
Acronym / sponsor ID: 5787-O
Conditions: Ostomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Hollister IncorporatedIndustry (pharma, biotech, devices)
Study start: 16 Mar 2015 (actual)
Primary completion: 20 Jan 2017 (actual)
Study completion: 3 Feb 2017 (actual)
First posted: 27 Mar 2015 (estimated)
Results: Posted 11 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Test Ostomy Barrier	Other	Device: Test Ostomy BarrierThe test product is a new Hollister ostomy barrier.
Control Ostomy Barrier	Other	Device: Control Ostomy BarrierThe control product is a currently marketed Hollister ostomy barrier.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Have healthy peristomal skin
Are within 12 weeks post op

Key exclusion criteria (3 listed)

Have a fistula, wound, lesion or suspected infection in the peristomal area
Are in-patient in healthcare facility

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Test Ostomy Barrier	Device	Test Ostomy Barrier
Control Ostomy Barrier	Device	Control Ostomy Barrier

Primary outcome

Stoma Related Cost of Care
Time frame: 12 weeks
12 week stoma related cost of care. Cost of care includes treatments related to ostomy and/or PSCs (topical medications, clinic visits, and selected accessory use), social impact of ostomy and/or PSCs (missed work/ appointments), ostomy-related hospitalizations, emergency department visits, physician/clinic visits, medication use and therapies, and product utilization.

1 secondary outcome

Peristomal Skin Complication Rate
Time frame: 8 weeks

Results and safety

Results posted to the registry on 11 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Ostomy Barrier	89	59
Control Ostomy Barrier	81	49

Primary outcome: Stoma Related Cost of Care

Time frame: 12 weeks. Least squares mean (95% Confidence Interval). Unit: USD

Measure	Test Ostomy Barrier n = 79	Control Ostomy Barrier n = 74
Value	223.73 (210.86 to 236.60)	260.19 (242.79 to 277.58)

Population analysed: The analysis population was defined as a modified ITT population which excluded subjects who 1. were inappropriately enrolled into the study (i.e. subjects initially enrolled but later found to NOT meet inclusion/exclusion criteria); (n=16) 2. did not receive the study device; (n=1) As such 153 (170-17) subjects were eligible for analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Ostomy Barrier	12 of 79 (15.2%)	6 of 79 (7.6%)	2 of 79
Control Ostomy Barrier	6 of 74 (8.1%)	11 of 74 (14.9%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Ostomy

Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
Ostomy - Ileostomy or Colostomy
Recruiting
Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Recruiting
Conducting Wound, Ostomy, and Continence (WOC) Nurse Telephone Follow-up for Post-discharge Ostomy Patients to Reduce Hospital Readmission
Ostomy
Recruiting
ColoSeal™ ICD System Safety and Feasibility Studies
Colorectal Cancer
Active, not recruiting
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
Rectal Cancer Surgery

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mark Kalifa study director

Hollister Incorporated

12 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Test Ostomy Barrier in people with Ostomy, run by Hollister Incorporated at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stoma Related Cost of Care (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02401412.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.